MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE® RESUSCITATION SYSTEM MODEL 100; CARDIAC CHEST COMPRESSOR, PRODUCT CODE: DRM

Model Number MODEL 100

Device Problem Erratic or Intermittent Display (1182)

Patient Problem No Patient Involvement (2645)

Event Date 07/21/2016

Event Type  malfunction  

Manufacturer Narrative

Visual inspection of the returned platform was performed, front and bottom enclosures were noted to be cracked.The battery lock was also broken.The autopulse platform is a reusable device and was manufactured on 02/12/2006.Therefore, this type of physical damages found during visual inspection is characteristic of normal wear and tear for the life of the device and is unrelated to the reported complaint.The display was also missing some pixels.Visual inspection of the battery(s/n (b)(4)) returned with the autopulse confirmed damaged edges, therefore the battery was stuck after insertion.Multiple test batteries were inserted and removed from the battery compartment without any issue.The archive data could not be downloaded as "the size of data structure is over limit" message was displayed.The functional testing was performed, the device passed all the tests.In summary customer's reported complaint about li-ion battery was stuck in autopulse was confirmed.The root cause for the reported complaint is related to battery being damaged at the edge.Both the battery compartment and battery connector are in a good condition.The root cause for missing pixel on the display is related to the damaged lcd.

Event Description

It was reported that li-ion battery did not come out of the autopulse.The customer inserted a li-ion battery normal, however the battery will not come out.Customer tried several times but the battery was stuck.Autopulse is not functional since the battery is depleted.This was found during shift check.During investigation of the returned device, it was identified that display screen was missing pixels.

• Brand Name: AUTOPULSE® RESUSCITATION SYSTEM MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR, PRODUCT CODE: DRM
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: joy patel ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192957
• MDR Report Key: 5870809
• MDR Text Key: 51925029
• Report Number: 3010617000-2016-00578
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001571
• UDI-Public: 00849111001571
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 08/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0700-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/21/2016
• Initial Date FDA Received: 08/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/12/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1